scholarly journals Review: necessary for protection even in minimal-risk research

Nature ◽  
2009 ◽  
Vol 458 (7237) ◽  
pp. 404-404
Author(s):  
David B. Resnik
Keyword(s):  
Minimal Risk ◽  
Risk Research

IRB Decision‐Making about Minimal Risk Research with Pregnant Participants

2021 ◽  
Vol 43 (5) ◽  
pp. 2-17
Author(s):  
Amina White ◽  
Christine Grady ◽  
Margaret Little ◽  
Kristen Sullivan ◽  
Katie Clark ◽  
...  
Keyword(s):  
Decision Making ◽  
Minimal Risk ◽  
Risk Research

scholarly journals Expert Perspectives on Oversight for Unregulated mHealth Research: Empirical Data and Commentary

2020 ◽  
Vol 48 (S1) ◽  
pp. 138-146 ◽  
Author(s):  
Laura M. Beskow ◽  
Catherine M. Hammack-Aviran ◽  
Kathleen M. Brelsford ◽  
P. Pearl O'Rourke
Keyword(s):  
Empirical Data ◽  
Qualitative Interviews ◽  
Ethical Conduct ◽  
Evidence Based ◽  
Minimal Risk ◽  
Diverse Group ◽  
Research Risks ◽  
Risk Research ◽  
Current Systems

In qualitative interviews with a diverse group of experts, the vast majority believed unregulated researchers should seek out independent oversight. Reasons included the need for objectivity, protecting app users from research risks, and consistency in standards for the ethical conduct of research. Concerns included burdening minimal risk research and limitations in current systems of oversight. Literature and analysis supports the use of IRBs even when not required by regulations, and the need for evidence-based improvements in IRB processes.

scholarly journals Via media: Role and responsibilities of the independent safety officer

2019 ◽  
Vol 3 (4) ◽  
pp. 147-151
Author(s):  
M. E. B. Holbein ◽  
Barbara N. Hammack ◽  
Ann J. Melvin ◽  
Tamsin A. Knox
Keyword(s):  
Research Study ◽  
Scientific Information ◽  
Safety Data ◽  
Minimal Risk ◽  
Middle Way ◽  
Study Progress ◽  
Study Investigator ◽  
Risk Research ◽  
Safety Officer ◽  
Regulatory Challenges

AbstractEvery research study that includes volunteer participants requires safety assurances in proportion to the risks of the study. Investigator-initiated clinical research can present unique regulatory challenges particularly for studies with a risk profile that warrants more oversight than minimal risk but less than for large, commercial, or high-risk research. The use of an independent safety officer (ISO) offers a middle way of right-sizing oversight to match the risk. ISOs are clinicians or researchers with relevant expertise who are independent of the investigator and the research study. Their relationship to the study is defined by a formal charter which is aligned with the protocol and Data and Safety Monitoring Plan to address the oversight process, responsibilities of the ISO, and clearly describe the variables to be monitored. The ISO responsibilities include reviewing safety data, adverse events, recruitment, demographics, study progress, data quality, protocol changes, and any new scientific information that pertains to the trial. Finally, the ISO reports in their review on any significant findings may propose modifications to the study or a need to stop the trial.

scholarly journals Implementation of a volunteer university student research assistant program in an emergency department: the nuts and bolts for success

CJEM ◽  
2015 ◽  
Vol 17 (5) ◽  
pp. 586-589 ◽  
Author(s):  
Patrick E. Steadman ◽  
Johanna Crudden ◽  
Kathy Boutis
Keyword(s):  
Emergency Department ◽  
University Student ◽  
Minimal Risk ◽  
Monetary Incentives ◽  
Research Assistant ◽  
Student Research ◽  
Patient Screening ◽  
Risk Research ◽  
University Course ◽  
Research Studies

AbstractProspective research studies often advance clinical practice in the emergency department (ED), but they can be costly and difficult to perform. In this report, we describe the implementation of a volunteer university student research assistant program that provides students exposure to medicine and clinical research while simultaneously increasing the capacity of an ED’s research program. This type of program provides 15 hours per day of research assistant coverage for patient screening and enrolment for minimal risk research studies, and screening for higher risk studies. The latter is true without the added burden or costs of co-administering university course credit or pay for service, which are common features of most of these types of programs currently in operation. We have shown that our volunteer-based program is effective for an ED’s research success as well as for its student participants. For other EDs interested in adopting similar programs, we provide the details on how to get such a program started and highlight the structure and non-monetary incentives that facilitate a program’s ongoing success.

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